Involvement of the Sodium Pump and Endogenous Digitalis-like Compounds in Bipolar Disorder (NA\K-MANIA)

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01322113
First received: March 23, 2011
Last updated: September 25, 2013
Last verified: March 2011
  Purpose

This study deals with the possible molecular mechanisms that underlie the etiology of bipolar disorders (BD). Previous studies have implicated Na+, K+-ATPase and endogenous digitalis-like compounds (DLC) in the depressive state of this disease. The possibility, however, that they are also involved in the manic phase of the disease was never addressed. The results of this study may have significant implications for the treatment of BD by DLC derivatives.


Condition
BIPOLAR DISORDER

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Involvement of the Sodium Pump and Endogenous Digitalis-like Compounds in Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Biospecimen Retention:   Samples Without DNA

30 cc of pperipheral blood will be taken every 4 months to determine circulating DLC levels in patients


Enrollment: 30
Study Start Date: May 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Na+, K+-ATPase/DLC system in BD
Bipolar patients in the various phases of the disease.

Detailed Description:

Depressive symptoms are the hallmark major depressive disorder, dysthymia and bipolar depression within the context of bipolar disorder (BD). They share clinical characteristics including depressed mood, anhedonia, and low energy and require medical treatment. The Na+, K+-ATPase is a major transporter in the plasma membrane which has an important role in regulating cell volume, cytoplasmic pH and Ca++ levels. Digitalis-like compounds (DLC); steroids identified as normal constituents of human brain, plasma and other tissues, exclusively interact with the Na+, K+-ATPase and induce numerous biological effects. We raised the hypothesis that Na+, K+-ATPase/DLC system is involved in BD based on studies from ours and other laboratories, which tested the involvement of this system in the depressive state of BD. The possibility that the interaction of DLC with the Na+, K+-ATPase is involved in the manic state of BD was scarcely investigated. To address this issue we intend to determine circulating DLC levels in patients with BD at different states of the disease;

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ALL BIPOLAR PATIENTS IN THE HADASSAH MEDICAL ORGANIZATION PSYCHIATRIC OUTPATIENTS CLINIC

Criteria

Inclusion Criteria:

  • BIPOLAR DISORDER PATIENTS

Exclusion Criteria:

  • NONE
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322113

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: RENA COOPER-KAZAZ, DR Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: DR RENA COOPER-KAZAZ, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01322113     History of Changes
Other Study ID Numbers: NA/K PUMP-MANIA-HMO-CTIL
Study First Received: March 23, 2011
Last Updated: September 25, 2013
Health Authority: ISRAEL MINISTRY OF HEALTH DIRECTOR GENERAL, ISRAEL':'

Keywords provided by Hadassah Medical Organization:
BIPOLAR
MANIA
DEPRESSION

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 14, 2014